High-Intensity Focused Ultrasound in Treating Participants With Intermediate and High-risk Prostate Cancer

PRIMARY OBJECTIVES:

I. Histologic assessment of cancer kill in the post high-intensity focused ultrasound (HIFU)
needle biopsy and excised treated lobe 2-4 weeks after treatment with HIFU.

II. Radiologic assessment of areas suspicious for residual cancer in the treated lobe on
multiparametric magnetic resonance imaging (mpMRI) and/or contrast enhanced ultrasound (CEUS)
2-4 weeks post-HIFU (immediately prior to radical prostatectomy).

SECONDARY OBJECTIVES:

I. Assessment of differences in tumor microenvironment, specifically upregulation of the
immune system, before and after HIFU treatment on both the treated and untreated lobes.

II. Assessment of HIFU parameters needed to achieve dose-escalation, in the event that such
escalation is needed per our study design.

OUTLINE:

HIFU PHASE: Participants undergo mpMRI and CEUS pre-HIFU treatment and then CEUS post-HIFU
treatment. Participants then undergo HIFU treatment over 2-2.5 hours.

PROSTATECTOMY PHASE: Within 2-4 weeks post-HIFU treatment, participants undergo mpMRI 1-2
days prior to radical prostatectomy. On the day of surgery, participants undergo CEUS prior
to radical prostatectomy.

After completion of study treatment, participants are followed up at 3 months.

Inclusion Criteria:

- Male having a diagnosis of clinically-significant prostate cancer (CsPCa) made within
the past 12 months (Gleason 7-9) with no evidence of metastatic disease; all outside
pathology will be re-reviewed at University of Southern California (USC) to verify
diagnosis

- Patients have elected to undergo radical prostatectomy (RP) as treatment of choice and
have to be a surgical candidate for RP; this determination will be made by the patient
in conjunction with their treating urologist and is current standard of practice

- Standard preoperative evaluation is performed and deemed satisfactory to proceed to
surgery as per their treating urologist

- Ability to understand AND willingness to sign a written informed consent

- Patients must be willing to undergo HIFU, CEUS, MRI and prostate biopsy pre-RP for
research purposes

Exclusion Criteria:

- Patients may not be receiving any other investigational agents or have received any
definitive prostate cancer (PCa)-specific treatment (en-bloc resection of bladder
tumors [EBRT], Brachytherapy etc) prior

- Patients with known metastases would be excluded from this clinical trial

- Uncontrolled inter-current illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, clinical
significant cardiac arrhythmia (rate controlled atrial fibrillation allowed), or
psychiatric illness/social situations that would limit compliance with study
requirements

- Patients with active autoimmune diseases or active immune suppressive therapy or
inflammatory bowel disease; a low dose steroid daily administration (equivalent
dexamethasone < 10mg/day) is acceptable

- Patients with rectal disease

- Patients who are unable to undergo MRI

- Patients with convincing evidence of extraprostatic extension or T4 disease on digital
rectal examination (DRE)